Evarrest Purple Book BLA 125392
- BLA number
- 125392
- Proprietary names
- Evarrest
- Proper names
- Fibrin Sealant Patch
- Applicant
- Ethicon, Inc.
- Center
- CBER
- First observed release
- 2020-08-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Evarrest | Fibrin Sealant Patch | 351(a) | 50.3MG FIBRINOGEN&203.2IU THROMBIN/IN^2; 4x4 IN | Patch | Topical | Pouch | Disc | Licensed | 2012-12-05 | |
| 002 | Evarrest | Fibrin Sealant Patch | 351(a) | 55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 4x4 IN | Patch | Topical | Pouch | Disc | Licensed | 2013-05-16 | |
| 003 | Evarrest | Fibrin Sealant Patch | 351(a) | 55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 2x4 IN | Patch | Topical | Pouch | Rx | Licensed | 2014-05-27 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-11-01 | U | 001 | Evarrest | 351(a) | Disc | Ethicon, Inc. |
| 2023-11-01 | U | 002 | Evarrest | 351(a) | Disc | Ethicon, Inc. |
| 2023-11-01 | U | 003 | Evarrest | 351(a) | Rx | Ethicon, Inc. |
| 2021-05-01 | U | 001 | Evarrest | 351(a) | Rx | Ethicon, Inc. |
| 2021-05-01 | U | 002 | Evarrest | 351(a) | Rx | Ethicon, Inc. |
| 2020-08-01 | R | 001 | Evarrest | 351(a) | Rx | Ethicon, Inc. |
| 2020-08-01 | R | 002 | Evarrest | 351(a) | Rx | Ethicon, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-11-01 | 001 | Evarrest | 351(a) | Disc | Licensed | 2012-12-05 |
| 2023-11-01 | 002 | Evarrest | 351(a) | Disc | Licensed | 2013-05-16 |
| 2023-11-01 | 003 | Evarrest | 351(a) | Rx | Licensed | 2014-05-27 |
| 2020-08-01 | 001 | Evarrest | 351(a) | Rx | Licensed | 2012-12-05 |
| 2020-08-01 | 002 | Evarrest | 351(a) | Rx | Licensed | 2012-12-05 |